NCT06176989

Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors

Recruiting now Phase 2 Last updated 8 April 2026

What this trial tests

Phase 2 trial testing Enasidenib in Metastatic Chondrosarcoma in 40 participants. Currently enrolling.

Timeline

4 March 2024

Primary endpoint
31 December 2027

31 December 2030

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	4 March 2024
Primary completion	31 December 2027
Estimated completion	31 December 2030
Sites	1 location across United States

Drugs / interventions tested

• Enasidenib (ENASIDENIB) — full drug profile →

Conditions studied

• Metastatic Chondrosarcoma — all drugs for Metastatic Chondrosarcoma →
• Locally Advanced Chondrosarcoma — all drugs for Locally Advanced Chondrosarcoma →
• Metastatic Sinonasal Adenocarcinoma — all drugs for Metastatic Sinonasal Adenocarcinoma →
• Locally Advanced Sinonasal Adenocarcinoma — all drugs for Locally Advanced Sinonasal Adenocarcinoma →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 120, any sex, with Metastatic Chondrosarcoma or Locally Advanced Chondrosarcoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

Cancers of the nasal cavity or skull base are rare. They often are not diagnosed until they are at an advanced stage, and they often spread to other parts of the body. These cancers may have mutations in a gene called IDH2. Researchers want to find out if a drug (enasidenib) that targets the IDH2 mutation can help people with these cancers.

Objective:

To test enasidenib in people with cancers of the nasal cavity or skull base.

Eligibility:

People aged 18 years and older with rare cancers of the nasal cavity or the base of the skull. Their cancer must have an IDH2 gene mutation, and it must have recurred locally or spread to other parts of the body. These cancers can include sinonasal undifferentiated carcinoma; olfactory neuroblastoma; sinonasal large-cell neuroendocrine carcinoma; poorly differentiated sinonasal adenocarcinoma; or chondrosarcoma.

Design:

Participants will be screened. They will have a physical exam with blood and urine tests and tests of their heart function. They will have imaging scans of their brain, skull base, neck, chest, abdomen, and pelvis. A sample of tumor tissue will be collected.

Enasidenib is a tablet taken by mouth with a glass of water. Participants will take the drug once a day, every day, in 28-day cycles. They will not have resting periods between cycles.

Participants will visit the clinic on the first day of each cycle to receive the tablets they will need to take at home until the beginning of the next cycle. They will keep a diary to record the time of each dose they take.

Participants may remain in the study as long as the drug is helping them....

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Altered metabolism in cancer: insights into energy pathways and therapeutic targets.
   Tufail M, Jiang CH, Li N. · · 2024 · cited 265× · PMID 39294640 · DOI 10.1186/s12943-024-02119-3
2. Epigenetics-targeted drugs: current paradigms and future challenges.
   Dai W, Qiao X, Fang Y, Guo R, et al · · 2024 · cited 131× · PMID 39592582 · DOI 10.1038/s41392-024-02039-0
3. The Interplay between Autophagy and Mitochondria in Cancer.
   Zdanowicz A, Grosicka-Maciąg E. · · 2024 · cited 9× · PMID 39273093 · DOI 10.3390/ijms25179143
4. Decoding the metabolic dialogue in the tumor microenvironment: from immune suppression to precision cancer therapies.
   Wang R, Zhuang J, Zhang Q, Wu W, et al · · 2025 · cited 4× · PMID 40696413 · DOI 10.1186/s40164-025-00689-6
5. Characterization of Somatostatin Receptor 2 Gene Expression and Immune Landscape in Sinonasal Malignancies.
   Xue E, Bracken-Clarke D, Krause H, Adeyelu T, et al · · 2024 · cited 2× · PMID 39682120 · DOI 10.3390/cancers16233931
6. Metabolic Checkpoints in CD8<sup>+</sup> T Cells within the Tumor Microenvironment: A Comprehensive Review and Emerging Insights.
   Ai J, Du Y, Xue Q, Peng W, et al · · 2026 · PMID 41694600 · DOI 10.7150/ijbs.125206